Pharmacokinetic and dose-finding study of osimertinib in patients with impaired renal function and low body weight.

ABSTRACT: The safety of osimertinib is limited in patients with severe or moderate renal impairment, or low body weight. This study aimed to investigate the safety, pharmacokinetics (PK) and recommended dose (RD) of osimertinib in patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) with impaired renal function and low body weight. Thirty-one eligible patients were enrolled and allocated into four cohorts: A, normal renal function (estimated glomerular filtration rate [eGFR] ≥ 50 mL/min/1.73 m² ) and normal body weight (≥45 kg); B, moderate renal impairment (eGFR = 30-50 mL/min/1.73 m² ); C, low body weight (<45 kg); and D, severe renal impairment (eGFR <30 mL/min/1.73 m² or undergoing dialysis). PK parameters and safety we

SUBMITTER: Fujiwara Y 

PROVIDER: S-EPMC10154887 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature